From Centro Nacional de Investigaciones Cardiovasculares (J.M.C., S.J.P., A.J.Q., A.F.-O., J.M.F.A., V.A., H.B., J.F.F., B.I., V.F.), Centro Integral de Enfermedades Cardiovasculares, Hospital Universitario Monteprincipe, Grupo HM Hospitales (J.M.C.), Hospital Clínico San Carlos, Universidad Complutense (A.F.-O., D.V.), Centro de Investigacion Biomedica en Red de Enfermedades Cardiovasculares (A.F.-O., P.L.S., F.M.O., J.M.V.R., V.A., H.B., A.C., B.I.), Unidad de Investigación Clínica y Ensayos Clínicos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (A.D.-F.), Health Research Institute, October 12 Hospital (H.B.), Fundación Jiménez Díaz University Hospital (J.F.F., B.I.), and Universidad Autonóma de Madrid (J.F.F.), Madrid, the Department of Cardiology, Hospital Universitario Salamanca, Salamanca (P.L.S.), Servicio de Cardiología, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia (F.M.O.), Servicio de Cardiología, Hospital Universitario A Coruña, Instituto de Investigación Biomédica A Coruña, La Coruña (J.M.V.R.), Servicio de Cardiología, Hospital Universitario de Cabueñes, Gijón (I.L.), the Cardiovascular Area and Coronary Unit, University Clinical Hospital of Santiago de Compostela, Santiago (M.R.-M.), the Department of Neurology, Hospital Universitario Rey Juan Carlos, Getafe (J.F.F.), and Servicio de Neurología, Hospital General Universitario de Alicante (N.L.), and the Department of Cardiology, Hospital Universitario de San Juan (A.C.), Alicante - all in Spain; the Department of Medical Statistics (S.J.P., R.O., T.C.) and the Centre for Global Chronic Conditions (P. Perel), London School of Hygiene and Tropical Medicine, and Imperial College NHS Trust (A.A.G.), London, and Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool (M.P.) - all in the United Kingdom; Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School (D.L.B.) - both in Boston; the Laboratory of Cardiovascular Prevention (M.C.R., M.B., A.F., L.O.-F.) and Laboratorio di Malattie Neurologiche, Dipartimento di Neuroscienze (E.B.), Istituto di Ricerche Farmacologiche Mario Negri, IRCCS, the Geriatric Unit, IRCCS Istituti Clinici Scientifici Maugeri (M.P.), and the Department of Clinical Sciences and Community Health, University of Milan (M.P.), Milan, and the Clinical and Rehabilitation Cardiology Unit, Emergency Department, San Filippo Neri Hospital, Rome (F.C., S.A.D.F.) - all in Italy; Berlin Institute of Health-Center for Regenerative Therapies, the Department of Internal Medicine and Cardiology (Virchow Klinikum), German Center for Cardiovascular Research, and the Center for Stroke Research Berlin, Charité Universitätsmedizin - all in Berlin (W.D., A.M.); the Department of Cardiology, University Hospital Besançon (F.S., F.E.), and University of Burgundy Franche-Comté (F.S., F.E.), Besançon, the Department of Clinical Pharmacology-Clinical Research Platform, Assistance Publique-Hôpitaux de Paris, Hôpital Saint Antoine, French Alliance for Cardiovascular Trials, Sorbonne Université, Paris (T.S.), the Department of Neurology, University Hospital of Dijon Burgundy (Y.B.), the Medical School of Dijon, University of Burgundy (Y.B.), and Hôpital François Mitterrand (Y.B.), Dijon - all in France; the 2nd Department of Medicine, Department of Cardiovascular Medicine of the 1st Faculty of Medicine, Charles University, and General University Hospital - both in Prague (A.L., J.-C.L.); Semmelweis Egyetem Városmajori Szív És Érgyógyászati Klinika, Budapest (G.B., B.M.); the Department of Heart Disease, Medical University, Wrocław, Poland (P. Ponikowski, M.K.); the Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium (F.V.W.); the Department of Cardiology, Zealand University Hospital, Roskilde, Denmark (M.M.S.); and the Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (V.F.).
N Engl J Med. 2022 Sep 15;387(11):967-977. doi: 10.1056/NEJMoa2208275. Epub 2022 Aug 26.
A polypill that includes key medications associated with improved outcomes (aspirin, angiotensin-converting-enzyme [ACE] inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular death and complications after myocardial infarction.
In this phase 3, randomized, controlled clinical trial, we assigned patients with myocardial infarction within the previous 6 months to a polypill-based strategy or usual care. The polypill treatment consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg). The primary composite outcome was cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization. The key secondary end point was a composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke.
A total of 2499 patients underwent randomization and were followed for a median of 36 months. A primary-outcome event occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio, 0.76; 95% confidence interval [CI], 0.60 to 0.96; P = 0.02). A key secondary-outcome event occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (hazard ratio, 0.70; 95% CI, 0.54 to 0.90; P = 0.005). The results were consistent across prespecified subgroups. Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group. Adverse events were similar between groups.
Treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care. (Funded by the European Union Horizon 2020; SECURE ClinicalTrials.gov number, NCT02596126; EudraCT number, 2015-002868-17.).
一种包含与改善预后相关的关键药物（阿司匹林、血管紧张素转换酶[ACE]抑制剂和他汀类药物）的复合药物已被提议作为心肌梗死后心血管死亡和并发症二级预防的一种简单方法。
在这项 3 期、随机、对照临床试验中，我们将在过去 6 个月内发生心肌梗死的患者随机分配至复合药物治疗策略组或常规治疗组。复合药物治疗包括阿司匹林（100mg）、雷米普利（2.5、5 或 10mg）和阿托伐他汀（20 或 40mg）。主要复合终点是心血管死亡、非致命性 1 型心肌梗死、非致命性缺血性卒中和紧急血运重建。主要次要终点是心血管死亡、非致命性 1 型心肌梗死或非致命性缺血性卒中的复合终点。
共有 2499 例患者接受了随机分组，中位随访时间为 36 个月。复合药物治疗组 1237 例患者中有 118 例（9.5%）和常规治疗组 1229 例患者中有 156 例（12.7%）发生了主要结局事件（风险比，0.76；95%置信区间[CI]，0.60 至 0.96；P=0.02）。复合药物治疗组 101 例患者（8.2%）和常规治疗组 144 例患者（11.7%）发生了主要次要终点事件（风险比，0.70；95%CI，0.54 至 0.90；P=0.005）。在预先设定的亚组中，结果一致。与常规治疗组相比，复合药物治疗组患者报告的药物依从性更高。两组的不良事件相似。
心肌梗死后 6 个月内使用包含阿司匹林、雷米普利和阿托伐他汀的复合药物治疗可显著降低主要不良心血管事件的风险。（由欧盟 Horizon 2020 资助；SECURE 临床试验.gov 编号，NCT02596126；EudraCT 编号，2015-002868-17。）
